Medivis Achieves FDA Clearance for AR Cranial Neurosurgery
Medivis Inc., a company focused on surgical intelligence technologies, has received FDA 510(k) clearance for its Cranial Navigation platform, establishing it as the first augmented reality system approved for intraoperative guidance in cranial neurosurgery. This regulatory decision represents the company’s second significant FDA clearance within the same year, following the earlier authorisation of its Spine Navigation platform, and reflects continued progress in the clinical application of augmented reality within surgical settings.
The Cranial Navigation platform uses augmented reality to align and spatially register patient imaging directly within the operative field. By integrating digital imaging data with the physical anatomy seen by the surgeon, the system provides a real-time visualisation of critical structures and pre-planned surgical trajectories. This capability is intended to support more efficient and confident intraoperative decision-making while reducing the need for surgeons to divert attention to external monitors. The design prioritises minimal disruption to existing workflows and aims to enhance precision without introducing additional procedural complexity.
A defining feature of the platform is its portability, which allows image-guided navigation to be deployed in environments where traditional navigation systems are impractical or unavailable. This includes intensive care units, where space, equipment limitations, and patient condition often restrict the use of conventional imaging guidance tools. By extending navigation capabilities beyond the operating theatre, the system broadens access to image-guided procedures in time-critical and resource-constrained settings.
One clinical area where this technology may have a notable impact is the placement of external ventricular drains. Current clinical data indicate that misplacement rates for these devices can reach up to 30 per cent, often resulting in repeated insertion attempts, increased risk of patient harm, and delays in critical treatment. Early clinical experience with the Medivis platform suggests that real-time augmented reality guidance at the bedside may significantly reduce these misplacements. Improved accuracy in these procedures has the potential to enhance patient safety, shorten intervention times, and contribute to better outcomes in acute neurological care.
The FDA clearance enables neurosurgeons to use augmented reality as a core component of cranial procedures, combining digital planning data with direct visual access to the surgical field. This development introduces a new approach to image-guided navigation by bringing advanced guidance tools into settings such as the ICU, where they have not previously been feasible. The approval supports broader clinical use at the bedside and lays the groundwork for deeper integration of augmented reality systems within standard operating room environments.
The Cranial Navigation platform incorporates several technical capabilities designed to support precision and efficiency throughout the surgical workflow. These include proprietary computer vision technology, anatomical segmentation, real-time data analysis, and advanced image processing, all of which work together to deliver context-aware guidance during procedures. The system is paired with lightweight augmented reality hardware that keeps essential information within the surgeon’s natural line of sight, reducing the cognitive load associated with frequent visual shifts away from the operative area.
In addition, the platform is designed to integrate smoothly into routine clinical practice, supporting data-driven decision-making in both traditional operating rooms and previously inaccessible environments such as bedside ICU procedures. This flexibility is intended to help standardise high-quality navigation support across diverse care settings.
The FDA clearances for both Cranial Navigation and Spine Navigation enable the use of established CPT add-on codes, including 61781 and 61783, which may support reimbursement pathways for providers adopting the technology. Medivis continues to advance the adoption of augmented reality across multiple surgical specialities and clinical environments, with the broader objective of making surgical intelligence a standard component of patient care worldwide.
